Effects of IMT on Respiratory, Diaphragmatic and Balance Functions, Exercise Capacity and QOL in People After Stroke

NCT06447272 | Not Yet Recruiting

• 1 other identifier: HE-OT2023/13
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized controlled trial. This current RCT study will be a continuing project based on the optimal IMT intensity identified from our ongoing study. This ongoing study (registered on ClinicalTrials.gov with the registration number NCT06267768) aims to explore the optimal IMT intensity for the recruitment of diaphragm muscles in people after a stroke. Based on this intensity, the aim of this RCT is to explore the effects of a 4-week protocol of IMT on respiratory function, balance control, exercise capacity, and quality of life in people after a stroke.

Conditions

Stroke

Keywords

Stroke; Inspiratory muscle training; Diaphragm; Balance control; Exercise capacity

Outcome Measures

Primary Outcomes (1)

• Diaphragmatic thickness

  The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).

  baseline, after 4 weeks of intervention

Secondary Outcomes (9)

• Forced Vital Capacity (FVC)

  baseline, after 4 weeks of intervention

• Forced Expiratory Volume in one second (FEV1)

  baseline, after 4 weeks of intervention

• Maximum Inspiratory Pressure (MIP)

  baseline, after 4 weeks of intervention

• Trunk Impairment Scale (TIS)

  baseline, after 4 weeks of intervention

• Sitting Balance

  baseline, after 4 weeks of intervention

Study Arms (2)

Sham IMT

SHAM COMPARATOR

conventional treatment + sham IMT

Other: sham inspiratory muscle training

Target IMT

EXPERIMENTAL

conventional treatment + target IMT

Other: target inspiratory muscle training

Interventions

sham inspiratory muscle training OTHER

This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)

Sham IMT

target inspiratory muscle training OTHER

This group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study).

Target IMT

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 40 and 80 years;
• breathing spontaneously;
• clinically diagnosed with ischemic and/or haemorrhagic stroke;
• stroke duration from onset between 1 and 12 months;
• no history of thoracic or abdominal surgery within the last 6 months;
• able to understand and follow verbal instructions;
• no facial palsy, or mild facial palsy without limitation of labial occlusion;
• capable of maintaining a resting sitting posture without feet support for at least 30 seconds;
• no cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of ≥ 26;
• able to independently walk at least 10 meters with or without an assistive device.

You may not qualify if:

• acute myocardial infarction or acute heart failure;
• acute pain in any part of the body;
• with respiratory illness or positive clinical signs of impaired respiratory function, such as shortness of breath, hypoxemia, chronic cough, or sputum retention;
• with chronic cardiovascular dysfunction;
• Trunk Impairment Scale (TIS) score ≥ 20;
• presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedure.

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Fang LIU

  Hong Kong Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang LIU

CONTACT

+8613603049475; s1350035@live.hkmu.edu.hk

William Wai Nam Tsang

CONTACT

wntsang@hkmu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 7, 2024
• Study Start: April 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share